Early Palliative Care for Patients With Haematological Malignancies

Acute Myeloid Leukemia Clinical Trial

— CALVI  

Official title:

Early Palliative Care for Patients With Haematological Malignancies: A Randomised Prospective Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03800095
• Other study ID #: CHU-406
• Secondary ID: 2017-A02515-48
• Status: Recruiting
• Phase: Phase 3
• Start date: March 14, 2019
• Est. completion date: December 31, 2023

Study information

• Verified date: March 2021
• Source: University Hospital, Clermont-Ferrand
• Contact: Lise LACLAUTRE
• Phone: 0473754963
• Email: drci[@]chu-clermontferrand.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Patients suffering from haematological disease present symptoms of discomfort and currently benefit from palliative care skills only for the management of their end-of-life. However, in medical oncology, more and more studies tend to demonstrate the benefit on the quality of life of an early collaboration between the two specialties.

Investigator did the hypothesis that early integration of palliative care with conventional haematological care could decrease discomfort symptoms and add a real benefit on the patients' quality of life .

Description:

Patients suffering from haematological disease present symptoms of discomfort and currently benefit from palliative care skills only for the management of their end-of-life. However, in medical oncology, more and more studies tend to demonstrate the benefit on the quality of life of an early collaboration between the two specialties.

Investigator did the hypothesis that early integration of palliative care with conventional haematological care could decrease discomfort symptoms and add a real benefit on the patients' quality of life .

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 140
• Est. completion date: December 31, 2023
• Est. primary completion date: August 14, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 70 Years and older

Eligibility

Inclusion Criteria:

• Patients are over 70 years old

• Patients from being diagnosed with acute myeloid leukemia and high-risk myelodysplastic syndrome or after the third line of therapy for high-grade lymphoma.

Exclusion Criteria:

• All patients with a curative project (induction chemotherapy ou allogenic transplantation)

• All patients in a terminal palliative status

• Patients who don't speak French,

• Patients not able to read and write

• Patients who don't agree to participate in the protocol

• Patients with psychiatric troubles or cognitive disorders

• Patients under guardianship or curatorship, deprived of freedom or under justice protection.

Related Conditions & MeSH terms

• Acute Myeloid Leukemia
• Diffuse Large B Cell Lymphoma
• Hematologic Neoplasms
• Lymphoma, Large B-Cell, Diffuse
• Myelodysplastic Syndrome
• Myelodysplastic Syndromes
• Neoplasms
• Palliative Care

Intervention

Drug:
• Early palliative care integration
The follow-up time for each patient is 12 months with evaluation of the main objective by a standardized questionnaire: The Functional Assessment of Cancer Therapy-Anaemia (FACT-An) Scale at 6 months. Throughout the study, patients included will receive conventional haematological care and the interventional arm will benefit in addition to a monthly consultation by a palliative care team.

Locations

Country	Name	City	State
France	Centre Hospitalier Métropole Savoie	Chambéry
France	Chu Clermont-Ferrand	Clermont-Ferrand
France	Chu Limoges	Limoges
France	Centre Léon Bérard	Lyon
France	Institut de Cancérologie de la Loire	Saint-Priest-en-Jarez
France	CH Jacques Lacarin	Vichy

Sponsors (5)

Lead Sponsor	Collaborator
University Hospital, Clermont-Ferrand	Association CEMSBM, Association des foulées de la Haute Lozère, Connaître et Combattre les Myélodysplasies, Fondation Apicil

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of life evaluation: standardized questionnaire	Evaluation of quality of life by a standardized questionnaire : Functional Assessment of Cancer Therapy-Anemia (FACT-An). The higher is the score the better is the quality of life. FACT-An is composed by five subscales: Physical Well-Being [score range 0-28], Social/Family Well-Being [score range 0-28], Emotional Well-Being [score range 0-24], and Functional Well-Being [score range 0-28] and specific questions concerning anemia [score range 0-80]. The score at each items is summed. The sum is multiplied par the number of items in the subscale and then divided by the number of items answered. This produces the subscale score. The subscale scores are added to derive total score [score range 0-188].	at 6 months
Secondary	Presence of discomfort symptoms	evaluated by Edmonton scale (depressive syndrome measured by the geriatric depression scale GDS)	at Day 0, 3 months, 6 months, 9 months, 12 months
Secondary	overall survival		at day 1 : from the randomization until the date of death or until 1 year [study end].
Secondary	Satisfaction of the care pathwaydesired by the patient	matching between patients desires writing in the medical file and the providing care	at 12 months or death
Secondary	cost-effectiveness analysis	The cost criteria selected will be all the direct medical costs inherent in care in both arms (costs of hospitalizations, consultations, treatments, medical devices).	at 12 months or death